FLUDARA 50MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance: FLUDARABINE PHOSPHATE

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50 mg

powder for solution for injection or infusion
Fludarabine phosphate

Read all of this leaflet carefully before
this medicine is given to you.
̈ Keep this leaflet. You may need to read it
again.
̈ If you have any further questions, ask
your doctor or pharmacist.
̈ If any of the side effects gets serious, or
if you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Fludara is and what it is used
for
2. Before you are given Fludara
3. How to use Fludara
4. Possible side effects
5. How to store Fludara
6. Further information

1.What Fludara is and what it is
used for

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What Fludara is and how it works:
Fludara is an intravenous injection or
infusion that stops the growth of new
cancer cells. All cells of the body produce
new cells like themselves by dividing.
Fludara is taken up by the cancer cells and
stops them dividing.
In cancers of the white blood cells (such
as chronic lymphocytic leukaemia), the
body produces many abnormal white
blood cells (lymphocytes) and lymph nodes
start to grow in various parts of the body.
The abnormal white blood cells cannot
carry out the normal disease fighting
functions and may push aside healthy
blood cells. This can result in infections,
a decrease in number of red blood cells
(anaemia), bruising, severe bleeding or
even organ failure.
What Fludara is used for:
Fludara is used in the treatment of B-cell
chronic lymphocytic leukaemia (B-CLL) in
patients with sufficient healthy blood cell
production.
First treatment for chronic lymphocytic
leukaemia with Fludara should only be
started in patients with advanced disease
having disease-related symptoms or
evidence of disease progression.

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2.Before you are given Fludara
Do not use Fludara:
̈ if you are allergic (hypersensitive) to
fludarabine phosphate or any of the
other ingredients of Fludara (see section
6 Further information)
̈ if you are breast-feeding
̈ if you have severe kidney problems
̈ if your red blood cell count is low,
because of a type of anaemia
(decompensated haemolytic anaemia)
Your doctor will have told you if you
have this condition.
୴ Tell your doctor, if you think any of
these may apply to you.
Take special care with Fludara:

̈ If your bone marrow is not working

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properly or if you have a poorly
functioning or depressed immune
system or a history of serious
infections
୴ Your doctor may decide to not give
you this medicine, or may take
precautions.
̈ If you feel very unwell, notice any
unusual bruising, more bleeding than
usual after injury, or if you seem to be
catching a lot of infections
୴ Tell your doctor if any of these apply
before your treatment.
̈ If during treatment you have a red to
brownish urine, or have a rash or any
blisters on your skin.
୴ Tell your doctor immediately.
These may be signs of a reduction in the
number of blood cells, which may be caused
either by the disease itself or the therapy.
It can last for up to a year, independent
of whether or not you had treatment with
Fludara before. During treatment with

Fludara also your immune system may
attack different parts of your body, or
your red blood cells (called ‘autoimmune
disorders’). These conditions can be lifethreatening.
If this occurs your doctor will stop your
treatment and you may receive further
medication such as transfusion of irradiated
blood (see below) and adrenocorticoids.
You will have regular blood tests during
treatment and you will be closely monitored
while you are being treated with Fludara.
̈ If you notice any unusual symptoms
of your nervous system such as
disturbed vision,
୴ Tell your doctor.
If Fludara is used for a long time, its effects
on the central nervous system are not
known. However patients treated with the
recommended dose for up to 26 courses
of therapy were able to tolerate it. In
patients on doses four times greater than
recommended blindness, coma and
death have been reported. Some of these
symptoms appeared delayed around
60 days or more after treatment has been
stopped.
̈ If you notice any pain in your side,
blood in your urine or reduced amount
of urine,
୴ Tell your doctor immediately.
When your disease is very severe, your
body may not be able to clear all the
waste products from the cells destroyed by
Fludara. This is called tumour lysis syndrome
and can cause kidney failure and heart
problems from the first week of treatment.
Your doctor will be aware of this and may
give you other medicines to help prevent it.
̈ If you need to have stem cells
collected and you are being treated
with Fludara (or have been),
୴ Tell your doctor.
̈ If you need a blood transfusion and
you are being treated with Fludara
(or have been),
୴ Tell your doctor.
In case you need a blood transfusion your
doctor will ensure that you only receive
blood that has been treated by irradiation.
There have been severe complications
and even death, from transfusions of
non-irradiated blood.
̈ If you notice any changes to your skin
either while you are receiving this
medicine or after you have finished
the therapy,
୴ Tell your doctor.
If you have or have had skin cancer
it may worsen or flare up again during
Fludara therapy or afterwards. You may
develop skin cancer during or after
Fludara therapy.
Other things to consider, while you are
treated with Fludara:
̈ Men and women, who are fertile, must
use effective contraception during
treatment and for at least 6 months
afterwards. It cannot be ruled out that
Fludara may harm an unborn baby. Your
doctor will carefully weigh the benefit of
your treatment against a possible risk
for an unborn child and, if you are
pregnant, will only treat you with
Fludara if clearly necessary.
̈ If you consider or are breast-feeding
you should not start it or continue while
on treatment with Fludara.
̈ If you need a vaccination, check with
your doctor, because live vaccinations
should be avoided during and after
treatment with Fludara.
̈ If you have kidney problems or if you
are over 65, you will have regular blood
and/or laboratory tests to check your
kidney function. If your kidney problems
are severe, you will not be given this
medicine at all (see also section 2, ‘Do not
use Fludara’ and section 3 How to use
Fludara).
Using other medicines:
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription. Ask your doctor or pharmacist
for advice before taking any medicine.

It is especially important to tell your doctor
about:
̈ pentostatin (deoxycoformycin), also used
to treat B-CLL. Taking these two drugs
together can lead to severe lung problems
̈ dipyridamole, used to prevent excessive
blood clotting or other similar substances.
They may reduce the effectiveness of
Fludara
̈ cytarabine (Ara-C) used to treat chronic
lymphatic leukaemia. If Fludara is
combined with cytarabine, levels of the
active form of Fludara in leukaemic cells
may rise. However, the overall levels in
the blood and its elimination from the
blood were not shown to have changed.
Older patients and Fludara:
People over 65, will have regular tests for
kidney function (see also section 3 How to
use Fludara).
People over 75, will be monitored
especially closely.
Children:
The safety and effectiveness of Fludara
in children has not been established.
Therefore, Fludara is not recommended
for use in children.
Pregnancy and breast-feeding:
Fludara should not be given to women who
are pregnant because animal studies and
very limited experience in humans have
shown a possible risk of abnormalities in
the unborn baby as well as early pregnancy
loss or premature delivery.
̈ If you are pregnant or you think you
may be pregnant, tell your doctor
immediately.
̈ If you are a woman who could become
pregnant, you must use effective
contraceptive methods during treatment
and for at least 6 months after
treatment (see section 2 ‘Before you are
given Fludara’).
̈ Men who have been given Fludara and
who could become fathers must use
reliable contraception during treatment
and for at least 6 months afterwards.
Your doctor will carefully weigh the benefit
of your treatment against a possible risk for
an unborn child and, if you are pregnant,
will only prescribe Fludara if clearly
necessary.
Breast-feeding:
You must not start or continue breastfeeding during your treatment with Fludara
as this medicine may interfere with the
growth and development of your baby.
Ask your doctor for advice before taking
any medicine
Driving and using machines:
Some people get tired, feel weak, have
disturbed vision, become confused, or
agitated or have seizures while they are
treated with Fludara. Do not try to drive or
operate machines until you are sure that
you are not affected.
Important information about some of
the ingredients of Fludara
This medicinal product contains less than
1mmol sodium per dose, i.e, essentially
sodium free.

3.How to use Fludara
Fludara should be administered under the
supervision of a qualified doctor experienced
in the use of anti-cancer therapy.
̈ For information for preparation of
the reconstituted or diluted solution,
see section 6 Further information /
information for medical or healthcare
professionals.
How Fludara is given:
Fludara is given in the form of a solution as
an injection or, mostly, as an infusion.
An infusion means that the medicine is
given directly into the blood stream by
a drip through a vein. One infusion takes
approximately 30 minutes.
Your doctor will make sure that Fludara is
not given beside the vein (paravenously).
However, if this happens, no severe local
adverse events have been reported.
How much Fludara is given:
The dose you are given depends on your
body surface area. This is measured in
square metres (m²), and is worked out by
your doctor from your height and weight.
The recommended dose is 25 mg fludarabine
phosphate/m² body surface area.
For how long Fludara is given:
The dose will be given once a day for
5 consecutive days.

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Package leaflet: information for the user



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If any of the side effects gets serious,
or if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

5.How to store Fludara
Keep out of the reach and sight of children.
Do not use Fludara after the expiry date
which is shown on the carton and vial.
The expiry date refers to the last day of that
month.
̈ Storage of Fludara as packed for sale
This medicinal product does not require
any special storage conditions.
̈ Storage of Fludara after reconstitution
For information for medical and healthcare
professionals, see section 6 Further
information, information for medicinal
and healthcare professionals.

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Below we list possible side effects by how
common they are. The rare side effects
(less than 1 in every 1,000 patients) were
mainly identified from post-marketing
experience.
̈ Very common means 1 or more in every
10 patients are likely to get these:
– infections (some serious);
– infections due to depressed immune
Children: Fludara is not recommended
system (opportunistic infections);
for use in children.
– infection of the lungs (pneumonia) with
possible symptoms like breathing
You will have regular blood tests during
difficulties and/or cough with or without
your treatment. Your individual dose will
fever;
be carefully adjusted according to the
– reduction in the number of blood
number of your blood cells and your
platelets (thrombocytopenia) with the
response to the therapy.
possibility of bruising and bleeding;
The dosage may be decreased if side
– lowered white blood cell count
effects are a problem.
(neutropenia);
If you have kidney problems or if you are – lowered red blood cell count (anaemia);
over the age of 65, you will have regular
– cough;
tests to check your kidney function. If your – vomiting, diarrhea, feeling sick (nausea);
kidneys do not work properly you may be
– fever;
given this medicine at a lower dose. If your – feeling tired (fatigue);
kidney function is severely reduced you will – weakness.
not be given this medicine at all (see also
̈ Common means between 1 and 10 in
section 2, ‘Do not use Fludara’).
every 100 patients are likely to get these:
If any Fludara solution is accidentally
– other blood related cancers
spilt:
(myelodysplastic syndrome, acute myeloid
If any of the Fludara solution comes into
leukaemia. Most patients with these
contact with your skin or the lining of your
conditions were previously, or at the
nose or mouth, wash the area thoroughly
same time or later treated with other
with soap and water. If the solution gets
cancer drugs (alkylating agents,
into your eyes, rinse them thoroughly with
topoisomerase inhibitors) or radiation
plenty of tap water. Avoid any exposure by
therapy;
inhalation.
– bone marrow depression
(myelosuppression);
If more Fludara is given than it should:
If you may have received an overdose your – severe loss of appetite leading to weight
loss (anorexia);
doctor will stop the therapy and treat the
– numbness or weakness in limbs
symptoms.
(peripheral neuropathy);
High doses can lead to a severely reduced
– disturbed vision;
number of blood cells.
– inflammation of the inside of the mouth
For Fludara given intravenously it has been
(stomatitis);
reported, that overdose can cause delayed – skin rash;
blindness, coma and even death.
– swelling due to excessive fluid retention
(oedema);
If a dose of Fludara is forgotten:
Your doctor will set the times at which you – inflammation of the mucous coat of the
digestive system from the mouth to the
are to receive this medicine. Talk to your
anus (mucositis);
doctor as soon as possible, if you think you
– chills;
may have missed a dose.
– generally feeling unwell.
If the treatment with Fludara is stopped:
̈ Uncommon means between 1 and 10 in
You and your doctor may decide to stop
every 1,000 patients are likely to get
your treatment with Fludara if the side
these:
effects are becoming too severe.
– autoimmune disorder (see section 2,
If you have any further questions on the
‘Take special care’).
use of this product, ask your doctor or
– tumour lysis syndrome (see section 2,
pharmacist.
‘Take special care’);
– confusion;
4.Possible side effects
– lung toxicity; scaring throughout the
lungs (pulmonary fibrosis), inflammation
Like all medicines, Fludara can cause side
of the lungs (pneumonitis), shortness of
effects, although not everybody gets them.
breath (dyspnoea);
If you are not sure what the adverse
– bleeding in the stomach or intestines;
reactions below are, ask your doctor to
– abnormal levels of the liver or pancreas
explain them to you.
enzymes;
Some side effects can be life-threatening.
̈ Rare means less than 10 in every 10,000
̈ If you have difficulty breathing, have
patients are likely to get these.
a cough, or have chest pain with or
– disorders of the lymph system due to
without fever. These may be signs of
a viral infection (EBV-associated
an infection of the lungs.
lymphoproliferative disorder);
̈ If you notice any unusual bruising,
– coma;
more bleeding than usual after injury
– seizures;
or if you seem to be catching a lot of
– agitation;
infections. These may be caused by
– blindness;
a reduced number of blood cells. This
– inflammation or damage of the nerve of
may also lead to an increased risk of
the eyes (optic neuritis; optic neuropathy);
(serious) infections, caused by organisms,
– heart failure;
that usually do not cause disease in
– irregular heart beat (arrhythmia);
healthy persons (opportunistic infections)
– skin cancer;
including a late reactivation of viruses,
– skin and/or mucous coat reaction with
for example herpes zoster.
redness, inflammation, blistering and
̈ If you notice any pain in your side,
tissue break down (Lyell‘s syndrome,
blood in your urine, or reduced amount
Stevens-Johnson syndrome);
of urine. These may be signs of tumour
lysis syndrome (see 2 ‘Take special care’). ̈ Frequencies not known
̈ If you notice any skin and / or mucous – inflammation of the bladder, which can
cause pain when passing urine, and
coat reaction with redness,
can lead to blood in the urine
inflammation, blistering and tissue
(haemorrhagic cystitis)
break down. These may be signs of a
severe allergic reaction (Lyell’s syndrome, – bleeding in the brain
Stevens-Johnson syndrome).
– bleeding in the lungs
̈ If you have palpitations (if you
suddenly become aware of your heart
beat) or chest pain. These may be signs
of heart problems.
୴ Tell your doctor immediately, if you
notice any of these effects.
This 5-day course of treatment will be
repeated every 28 days until your doctor
has decided that the best effect has been
achieved (usually after 6 courses).
How long the treatment lasts depends on
how successful your treatment is and how
well you tolerate Fludara. The repeat course
may be delayed if side effects are a problem.

6.Further information
What Fludara contains:
̈ The active substance is fludarabine
phosphate.
̈ The other ingredients are mannitol and
sodium hydroxide.
The powder of Fludara is provided in 10-ml
glass vials. Each vial contains 50 mg
fludarabine phosphate. 1 millilitre of
reconstituted solution contains 25 mg
fludarabine phosphate.
What Fludara looks like and contents of
the pack:
Fludara is a sterile white to off-white
powder for solution for injection or
infusion. The powder is reconstituted with
water for injection and further diluted.
The reconstituted solution is clear and
colourless.
Fludara is available in packs containing
5 vials.
Marketing Authorisation Holder:
Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
The Netherlands
Manufacturer:
Bayer Pharma AG, D-13353 Berlin,
Germany
This leaflet was last approved in :

03/2011


Local representative:
Genzyme Therapeutics Ltd
4620 Kingsgate
Cascade Way
Oxford Business Park South
Oxford OX4 2SU
Tel: +44(0)1865 405 200
This medicinal product is authorised
in the Member States of the EEA
under the following names:
Belgium: Fludara
France: Fludara
Germany: Fludara
Greece: Fludara
Ireland: Fludara
Italy: Fludara
The Netherlands: Fludara
Portugal: Fludara
Spain: Beneflur
UK: Fludara

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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